U.S. patent application number 14/712524 was filed with the patent office on 2015-12-10 for screw-driven handles and systems for fiducial deployment.
The applicant listed for this patent is Cook Medical Technologies LLC. Invention is credited to Triona Campbell, Michael Clancy, Fionan Keady, Darach McGrath, Patrick Mulcahy, Ciaran Toomey.
Application Number | 20150351862 14/712524 |
Document ID | / |
Family ID | 53268913 |
Filed Date | 2015-12-10 |
United States Patent
Application |
20150351862 |
Kind Code |
A1 |
Clancy; Michael ; et
al. |
December 10, 2015 |
Screw-Driven Handles and Systems for Fiducial Deployment
Abstract
Embodiments include a fiducial deployment system with a handle
configured for actuation of same. A fiducial may include one or
more protuberances configured to engage one or more slots in a
needle of the system. The needle may be configured to deliver a
plurality of fiducials to a target location in serial fashion, one
at a time. In certain embodiments, echogenic placement of fiducials
may present certain advantages. The handle includes an actuation
mechanism with rotatable housing portion or member configured for
incrementally or otherwise controlledly deploy one or more
fiducials at a time by advancing a stylet through and/or retracting
the body of a slotted needle in which fiducials are disposed with a
fiducial protrusion extending into the needle slot, which also
includes retaining structures that do not impede the needle
lumen.
Inventors: |
Clancy; Michael; (Limerick,
IE) ; McGrath; Darach; (Co. Tipperary, IE) ;
Campbell; Triona; (Co. Clare, IE) ; Mulcahy;
Patrick; (Co. Tipperary, IE) ; Keady; Fionan;
(Co. Galway, IE) ; Toomey; Ciaran; (Co. Cork,
IE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cook Medical Technologies LLC |
Bloomington |
IN |
US |
|
|
Family ID: |
53268913 |
Appl. No.: |
14/712524 |
Filed: |
May 14, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62009587 |
Jun 9, 2014 |
|
|
|
Current U.S.
Class: |
600/424 |
Current CPC
Class: |
A61B 2090/0804 20160201;
A61B 17/3468 20130101; A61B 2090/373 20160201; A61B 2090/034
20160201; A61B 2090/0807 20160201; A61B 2090/3966 20160201; A61B
2090/3782 20160201; A61B 2090/3987 20160201; A61B 90/39 20160201;
A61B 2090/3925 20160201 |
International
Class: |
A61B 19/00 20060101
A61B019/00 |
Claims
1. A screw-driven handle for a fiducial deployment system
comprising: a fiducial deployment needle retaining for distal
deployment, in a controlled serial manner, a plurality of
fiducials; an advancement mechanism for said fiducial deployment,
the advancement mechanism comprising: an elongate handle member
defining a central longitudinal axis and handle lumen; an elongate
rotatable housing member affixed to the handle member and defining
an inner wall having helical housing threads; a screw member
disposed in the rotatable housing member and defining an outer wall
having helical screw threads; and a stylet disposed longitudinally
through the deployment needle, extending proximally through the
handle lumen and at least a portion of the rotatable housing
member, wherein the stylet is affixed to the screw member.
2. The handle of claim 1, further comprising a guide bar attached
to the screw member and extending proximally through at least a
portion of the handle member.
3. The handle of claim 1, wherein the screw member is
longitudinally movable in a housing lumen of the rotatable housing
member.
4. The handle of claim 3, wherein the screw member advances or
withdraws longitudinally within the housing lumen when rotational
force is applied to the housing member.
5. The handle of claim 4, wherein a single full rotation of the
housing member effects distal movement of the stylet by a distance
corresponding to a distal-needle-end deployment of a predetermined
number of the plurality of fiducials.
6. The handle of claim 1, further comprising a connector plate
formed at a proximal end of the handle member.
7. The handle of claim 6, wherein the deployment needle is affixed
to the connector plate.
8. The handle of claim 6, wherein the rotatable housing member
further defines a recessed portion formed on the inner wall.
9. The handle of claim 8, wherein the connector plate is held in
place by the recessed portion formed on the inner wall of the
rotatable housing member.
10. The handle of claim 1, wherein the handle member extends
longitudinally through at least a portion of the rotatable housing
member.
11. The handle of claim 1, wherein the handle member further
defines a laterally protruding handle portion at a proximal end of
the handle member.
12. The handle of claim 11, wherein the deployment needle is
affixed to the laterally protruding handle portion.
13. The handle of claim 11, wherein the housing member further
defines a laterally protruding housing portion at the distal end of
the housing member.
14. The handle of claim 13, wherein the housing member is rotatably
engaged to the handle member by the laterally protruding housing
portion engaging with the laterally protruding handle portion.
15. A medical device handle configured for controlled lengthwise
stylet advancement through a cannula such as a fiducial needle, the
handle comprising: an elongate handle body defining a longitudinal
handle lumen; an elongate cannula attached directly or indirectly
to a proximal end portion of the handle body, the cannula defining
a longitudinal cannula lumen in mechanical communication with the
handle lumen; an elongate housing body defining a longitudinal
housing lumen; a threaded screw member disposed within the housing
lumen; and a stylet extending distally from the screw member into
the cannula lumen, configured such that rotation of the housing
member effects a longitudinal movement of the screw member and the
stylet relative to the longitudinal housing lumen and the
longitudinal handle human.
16. The medical device handle of claim 15, wherein a 360-degree
rotation of the housing body is effective to move the stylet
distally by a predetermined increment corresponding to the
deployment of a predetermined number of fiducials from the distal
end of the fiducial needle.
17. The medical device handle of claim 15, further comprising a
connector portion formed at the proximal end of the handle
body.
18. The medical device of claim 17, wherein the elongate cannula is
attached to the connector portion.
19. The medical device of claim 15, wherein the handle body further
defines a longitudinally protruding connector portion as an
integral portion of the handle body.
20. The medical device of claim 19, wherein the elongate cannula is
attached to the longitudinally protruding connector portion.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a U.S. non-provisional application which
claims priority under 35 USC .sctn.119 to U.S. provisional
application Ser. No. 62/009,587, filed Jun. 9, 2014, which is
incorporated by reference herein in its entirety.
TECHNICAL FIELD
[0002] Embodiments disclosed herein relate generally to a medical
device system including one or more fiducials and methods of use
for same. More particularly, the disclosed embodiments pertain to
handle mechanisms and systems including same for endoscopically
deploying fiducials, and methods of use for same.
BACKGROUND
[0003] Medical procedures often require locating and treating
target areas within a patient. Focused, dose-delivery radiation
therapy requires locating the target with a high degree of
precision to limit damaging healthy tissue around the target. It is
particularly important to know or estimate the precise location of
the target in radiation oncology because it is desirable to limit
the exposure of adjacent body parts to the radiation in a patient
already suffering the depredations of cancer. However, in all
treatment procedures, whether radiologic or otherwise, it is most
desirable to be able to accurately target a region to be
treated.
[0004] In many applications, it is not possible to directly view a
treatment target or portion thereof (such as, for example, a
cancerous tumor, cyst, pseudocyst, or other target) that needs to
be acted on in some manner. As one example, when treating a lung or
pancreatic tumor with radiation, it may not possible to view the
actual tumor within the patient immediately before the radiation
treatment. It is therefore highly advantageous to have some
mechanism for permitting the tumor to be located accurately so that
the radiation treatment can be targeted at the tumor while avoiding
damage to healthy tissue.
[0005] Even for target regions that may be visualized using CAT
(computer-assisted tomography) scans, MRI (magnetic resonance
imaging), x-rays, ultrasound, or other techniques, difficulties
often arise in targeting a treatment. This is particularly true for
target regions within a torso of a patient and soft tissue regions.
Due to the mobility of tissues in those regions (e.g., movement of
internal organs during respiration and/or digestion, the movement
of breast tissue with any change of body position, etc.), a target
region may not remain fixed relative to anatomical landmarks and/or
to marks that can be placed onto an external surface of a patient's
body during one of those visualization procedures.
[0006] Several techniques have been developed to address this
problem. One such technique is to place markers into the patient
along the margins of the target region. The markers may be active
(e.g., emitting some kind of signal useful in targeting a therapy)
or passive (e.g., non-ferromagnetic metallic markers--called
fiducials--that can be used for targeting under ultrasound, MRI,
x-ray, or other targeting techniques, which may be included in a
treatment device).
[0007] A fiducial is typically formed of a radio-opaque material
that the target can be effectively located and treated with a
device that targets a site using the fiducials as positional
markers under radiographic detection. Typically, the fiducials may
be inserted into the patient during a simple operation.
Percutaneous placement is most commonly used. However, use of
minimally-invasive placement via an endoscope has recently
developed for fiducial placement into a patient's internal organs.
For example, percutaneous placement of fiducials along the margins
of a pancreatic tumor can be complex and painful (particularly for
obese patients, where the needle size is necessarily larger).
Another process using percutaneously implanted objects in a patient
is brachytherapy. In brachytherapy, radioactive sources or "seeds"
are implanted into and/or adjacent a tumor to provide a high dose
of radiation to the tumor, but not the healthy tissue surrounding
the tumor.
[0008] FIGS. 1A and 1B show longitudinal sectional views of a
two-piece introducer 100 of the prior art useful for placement of
brachytherapy seeds or fiducials. Referring first to FIG. 1A, the
introducer 100 includes a needle 102 and a stylet 104 slidably
disposed within the needle 102. The stylet 104 includes a first
handle 101 and a blunt distal end 106. The needle 102 includes a
second handle 103 and a bevel-tipped cannula 108 extending through
the second handle 103. The cannula 108 is configured to hold a
seed/fiducial 110. The cannula 108 has a distal tip 105 configured
for percutaneous implantation of the seed/fiducial 110 into the
patient.
[0009] In a "pre-loaded configuration," the seed/fiducial 110 is
retained in the cannula 108 by a plug 112 made from bone wax or
other suitable bio-compatible material(s). This is typically
accomplished by a "muzzle-loading" technique where the fiducial is
placed into the distal needle and then held in place by the bone
wax plug. This can present some challenges, as the bone wax plug
112 can be visible as an artifact in the patient, potentially
interfering with clear visualization of body structures or
treatment devices. With this configuration, the cannula 108 must be
withdrawn and reloaded after delivery of each seed/fiducial 110. If
the target locations for the fiducials are very far apart, use of a
single percutaneous introducer cannula/trocar for multiple
introductions of the cannula 108 may not be possible. In such a
circumstance, the patient must endure several percutaneous
punctures (and the increased attendant risk of infection for
each).
[0010] To implant the desired arrangement of seeds/fiducials 110 at
a target location in a patient, an operator pushes the cannula 108
in a first direction (arrow A) to insert the tip 105 into the
patient (typically under fluoroscopic visualization). The operator
then pushes the second handle 103 further in the first direction to
position the tip 105 at the desired depth within the patient where
a seed/fiducial 110 is to be implanted. Throughout this motion, the
operator moves the needle 102 and the stylet 104 together as a
unit. At the desired depth/location, the operator grasps the first
handle 101 with one hand and the second handle 103 with the other
hand. Then, the operator holds the first handle 101 stationary
while simultaneously sliding the second handle 103 back in a second
direction (arrow B) toward the first handle 101. As shown in FIG.
1B, this movement causes the cannula 108 to retract over the
seed/fiducial 110 to implant it in the patient. Alternatively, the
operator may move the first handle 101 in the first direction
(arrow A) while sliding the second handle 103 back in the second
direction (arrow B). This causes the stylet 104 to push the seeds
110 out of the cannula 108. The procedure is then repeated to place
other seeds/fiducials 110. When being used for targeting of
radiation therapy, a minimum of three fiducials is typically
required.
[0011] As will be appreciated from the disclosed structure, after
deploying one fiducial, one may alternatively reload the introducer
100 from the proximal end by completely withdrawing the stylet 104,
then placing another fiducial into the needle lumen and advancing
it therethrough to a second location to which the distal needle tip
105 has been directed (a "breech-loading" technique). Provided that
the fiducial target sites are sufficiently close together to allow
this technique, it can reduce the number of percutaneous punctures
or other access procedures needed to place more than one fiducial.
However, it creates a problem for procedures where ultrasound is
being used or is to be used in the near-future because it
introduces air pockets into the tissue and related fluids. Those
air pockets with tissue and/or fluid are echogenic in a manner that
can interfere with ultrasound visualization of a target area and/or
tools being used to diagnose or treat in/around the area. In some
brachytherapy techniques, a series of fiducials may be preloaded
into the needle--either separately or connected by a suture or
similar device--then placed together in fairly close proximity;
however, such a technique typically is not effective for placing
three or more fiducials in sufficiently disparate locations to use
for targeting a treatment relative to, for example, margins of a
tumor. This may also be true for multifiducial systems that rely
upon a distal plug to retain fiducials, which are thereafter
released freely, in contrast with systems according to the present
invention, which are configured for controlled serial release
(e.g., one at a time, two at a time, or some other user-controlled
retention and release of a pre-determined number of fiducials).
[0012] The process is similar when implemented endoscopically in
the manner developed rather recently, except that the needle and
stylet are of the type known in the art for use through the working
channel of an endoscope. One limitation of current endoscopic
techniques is the size of fiducial that can be introduced. With the
size limitation of endoscope working channels, the largest needle
that can typically be used without risking bending, crimping,
curving or otherwise damaging a needle (that does not have an
internal stylet or other support) during advancement out of the
endoscope to an anatomical target is a 19-gauge needle. This limits
the size of the fiducial that can be introduced through the needle
lumen using current, cylindrical fiducials. The endoscopic
technique generally suffers from the same reloading problems as
described above. Even though the external percutaneous punctures
are not an issue, having to withdraw and reload takes up valuable
time and complicates the procedure, potentially requiring
additional personnel, whether only the stylet is withdrawn for
"breech-loading" or the entire device is withdrawn for
"muzzle-loading."
[0013] It would be desirable to use ultrasound, and particularly
endoscopic ultrasound (EUS) for navigation and placement of
fiducials. As such it would be desirable to provide and use the
largest possible fiducial that will provide improved echogenicity
based on its size and echogenic profile. It would be desirable to
provide multiple fiducials in a needle that can be introduced in a
controlled serial manner (one, or some other pre-determined number,
at a time) rather than requiring manual reloading after placement
of each fiducial.
BRIEF SUMMARY
[0014] Embodiments of a fiducial deployment system described herein
may include one or more of: one or a plurality of fiducials having
one or more protuberances, a slotted needle configured for
delivering a plurality of fiducials in serial fashion where the
slot receives the fiducial protuberances without a detent that
occupies any internal diameter needle lumen portion, a handle
configured for controlling the serial delivery by user-operated
deployment of a predetermined number of fiducials, and a method of
delivering fiducials to a target region.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIGS. 1A-1B show a prior art fiducial introducer and method
of use;
[0016] FIGS. 2A-2C show an embodiment of a fiducial from,
respectively, top, side, and transverse section views;
[0017] FIG. 3 shows a top view of a slotted needle embodiment;
[0018] FIG. 3A shows a top view of another slotted needle
embodiment;
[0019] FIGS. 4-4B show, respectively, a top perspective view, a
longitudinal section view, and a transverse section view of a
distal fiducial deployment system portion;
[0020] FIGS. 5A-5C show a method of placing fiducials;
[0021] FIGS. 6A-6B show a handle embodiment for a fiducial
deployment system;
[0022] FIGS. 7-7D show, respectively, an external view, an
internal-component view, a top-perspective view of the internal
components, a second internal component view, and a longitudinal
section view of an advancement mechanism embodiment for a fiducial
deployment system; and
[0023] FIGS. 8-8D show, respectively, an external view, an internal
components view, two longitudinal section views, and a
top-perspective view of the internal components of a second
advancement mechanism embodiment for a fiducial deployment
system.
DETAILED DESCRIPTION
[0024] The terms "proximal" and "distal" are used herein in the
common usage sense where they refer respectively to a
handle/doctor-end of a device or related object and a
tool/patient-end of a device or related object.
[0025] A variety of fiducial and needle configurations may be used
in keeping with the present embodiments including those described
in U.S. Pat. App. Publ. Nos. 2010/0280367; 2011/0152611 to Ducharme
et al.; 2013/0006101 to McHugo et al.; 2013/0006286 to Lavelle et
al.; and 2013/0096427 to Murray et al., each of which is
incorporated by reference herein in its entirety. One embodiment,
illustrated with reference to FIGS. 2A-2C, of a fiducial 400 has a
generally columnar body that is generally cylindrical with a
generally circular transverse cross-section. A longitudinal surface
face of the body may be dimpled to enhance its ability to reflect
ultrasound waves and thereby provide a desirable echogenic profile.
This dimpled characteristic may alternatively be embodied as a
different irregular, patterned, or textured surface feature (e.g.,
knurled, ribbed) that may enhance the echogenicity of the fiducial
400, which will aid in visualizing it during EUS-guided placement,
and allow it to be used in ultrasound visualization of a target
site being marked by one or more fiducials 400 (e.g., a tumor).
[0026] Such a fiducial 400 preferably will be formed of a
radio-opaque, non-ferromagnetic material such as, for example,
gold, platinum, palladium, iridium, or alloys thereof, with one
preferred embodiment including an alloy of palladium with rhenium
(advantages of which may include desirable radio-opacity,
market-price stability superior to gold, and
ultrasound-reflectivity/echogenicity due to density). Being
radio-opaque will allow the fiducial to be used in deployment
techniques using fluoroscopy, as well as making it
detectible/visualizable by radiographic means during a treatment or
other procedure where it may be desirable to know the location(s)
of one or more fiducials. Being non-ferromagnetic will lessen the
likelihood that visualization techniques or other procedures
employing magnetic fields such as, for example, MRI, will re-orient
or otherwise dislodge a fiducial. Echogenic construction of a
fiducial or needle may be enhanced by surface texture, but can also
be provided by structural inclusions such as embedded bubbles or
beads that provide for a different ultrasound reflectivity than
material surrounding them. Fiducials may also be coated with a
material (e.g., parylene) configured to reduce backscatter during
radiography.
[0027] In a preferred embodiment, the fiducial 400 is configured
and dimensioned for passage through and release from a needle
lumen. For an endoscopic delivery system, the fiducial body 402
(exclusive of the protuberance) preferably will have an outer
diameter (OD) of about the same or less than the inner diameter
(ID) of a needle lumen, but the OD of the fiducial body preferably
will be no greater than the needle ID. As used herein, the OD of
the fiducial refers to an imaginary circle (or other geometric
shape) whose outermost boundaries all fit within the ID of the
needle lumen. In other words, it is preferable that the fiducial is
dimensioned to fit slidably into the needle lumen, except the
protuberance, which projects into the slot.
[0028] The longer body portion distal of the protuberance can help
make certain that, during deployment through a needle, a first
fiducial distal of this second fiducial will be fully advanced out
of the needle before that second fiducial is positioned for
deployment, as will be made clearer with reference to FIGS. 7-8D
below. Accordingly, in many preferred embodiments, the fiducial
protuberance (of the second and successive fiducials) will be
nearer its proximal end than its distal end, so that the distal
fiducial body portion projects sufficiently distally that it will
advance the preceding first fiducial completely out of the needle
lumen by the time that the second fiducial is in a position to be
deployed (see FIGS. 4A-4C, 7-8D, and corresponding text). It should
be appreciated that, even if all surfaces of the central fiducial
portion 402 and protuberance 408 are generally smooth, the
preferred materials forming the fiducial 400 and the presence of
the protuberance 408 may provide a desirable echogenic profile that
is readily visualizable under ultrasound at a resolution sufficient
for locating and/or navigating it in a patient's body.
[0029] The fiducial 400 has a generally cylindrical body 402 formed
as a mass with a generally circular transverse cross-section along
its proximal and distal end sections. A protuberance 408 projects
from the longitudinal circumferential face 406 of the fiducial body
402. As viewed from the top, the protuberance 408 is generally
obround. The irregular shape and increased surface area (as
compared to a typical cylindrical fiducial of the type used in
plug-ended systems and/or systems with some type of lumen-occupying
detent) preferably enhances the echogenicity of the fiducial, which
preferably will already be desirably high due in part to its
composition.
[0030] The protuberance 408 includes protuberance end faces 407
that may provide one or more of chamfered, filleted, and radiused
transition to the outer face 406 of the body 402. The body 402 is
generally a right cylinder, but for the protuberance 408. In this
embodiment, the protuberance 408 is rounded and substantially
parallel to the longitudinal central axis of the fiducial body, and
it is about one half the length of the body 402, and it is centered
along the body length. In a preferred embodiment, the fiducial 400
is configured and dimensioned for passage through and release from
a needle lumen. For an endoscopic delivery system, the fiducial
body (exclusive of the protuberance) will have an outer diameter
(OD) of about the same or less than the inner diameter (ID) of a
needle lumen, but the fiducial body OD preferably will be no
greater than the needle ID. The protuberance 408 will engage and
ride along through a needle slot.
[0031] Dimensions of one exemplary embodiment are also described
with reference to FIGS. 2A-2C. In one exemplary embodiment the body
402 is about 0.12 inches (3.05 mm) long and has an OD of about
0.034 inches (0.86 mm). The protuberance 408 is about 0.06 inches
(1.5 mm) long and is aligned along a midline of the body. The
protuberance 408 projects about 0.008 inches (0.2 mm) above the OD
of the body 402 and is about 0.011 inches (0.28 mm) wide. These
measurements and proportions may be varied in other embodiments
while remaining within the scope of the presently-claimed material.
For example, the protuberance may be more distally or proximally
located, and may be at an angle relative to the midline such that
it partially spirals around the outer surface of the body.
[0032] FIG. 2C shows an end view of a transverse section taken
along line 2C-2C of FIG. 2A. It shows one embodiment of general
proportions of a fiducial body and protuberance of the present
system.
[0033] FIG. 3 shows an embodiment of a fiducial introduction needle
800. The needle 800 is illustrated with a beveled distal tip 802.
Its tubular cannula body 804 includes a longitudinal needle slot
806 along a distal end region of the cannula 804. The slot 806
preferably includes at least one detent including at least one
detent surface, and more preferably two detents. The slot 806 is
shown as being open through the entire wall of the cannula 804, but
it should be appreciated that the slot may extend less than the
thickness of the needle wall, such that it is embodied as a
groove.
[0034] In the embodiment of FIG. 3, the detent is formed as a
narrowed portion 807 of the slot 806 between two tabs 808. The tabs
808 are generally trapezoidal, but may have a different geometry in
other embodiments. As shown in FIG. 3A, in certain preferred
embodiments, the tabs 808 may be located immediately adjacent the
distal bevel (e.g., to maximize efficiency of advancing a fiducial
past them and out of the needle while minimizing residual overlap
of a deployed fiducial with the beveled portion of the distal
needle tip). Each of the transitions between the edge 806a of the
needle slot 806, the proximal tab edge 808a, central tab edge 808b,
and distal tab edge 808c may be cornered (e.g., chamfered or
filleted) or rounded (e.g., radiused). The tabs 808 preferably are
near the distal end of the slot 806.
[0035] The body wall cannula 804 generally circumferentially
defines a needle lumen 810 configured to allow sliding passage
therethrough of a fiducial such as, for example, a fiducial (e.g.,
as shown in FIGS. 2A-2C or others that would readily pass through
the needle lumen 810, preferably with controllable retention of the
fiducial(s) by the tabs 808). The needle may be constructed from a
nickel-titanium alloy, cobalt-chromium (CoCr) alloy, stainless
steel or any other suitable material. Its tip may have a different
geometry than the beveled configuration shown. In an alternative
embodiment, the tabs 808 may meet such that they will be forced to
flex upward and/or outward to a greater degree to allow passage of
a protuberance on a fiducial. And, the outer surface of the needle
may be dimpled or otherwise textured to provide enhanced
echogenicity.
[0036] An exemplary needle embodiment is also described with
reference to FIG. 3, which exemplary needle embodiment may be
configured and dimensioned for use with the exemplary fiducial
embodiment described above with reference to FIGS. 2A-2C. In one
such exemplary needle embodiment, the ID of the needle lumen is at
least about 0.034 inches (0.86 mm). The OD of the needle is about
0.042 inches (1.07 mm; about 19-gauge), with a wall-thickness of
about 0.008 inches (0.2 mm). The slot portion proximal of the tabs
is about 0.02 inches (0.5 mm) wide and about 0.42 inches (about
10.7 mm) long. Each of the tabs extends about 0.06 inches (0.15 mm)
out of the slot edge and has a slot-facing edge that is about 0.02
inches (0.5 mm) long (not including the proximal and distal angled
transitions from the slot edge, which are radiused at about 0.005
inches (0.13 mm)). These measurements and proportions may be varied
in other embodiments, including those illustrated herein, while
remaining within the scope of the presently-claimed material. For
example, the particular dimensions of a slot, tabs, and fiducial
may be configured for use with a 22-gauge needle having a desirable
balance of flexibility and stiffness, as well as including a distal
needle tip bevel of about 30.degree., a slot width of about 0.014
inches (about 0.36 mm) with slot tabs separated only by about 0.006
inches (about 0.15 mm) across the slot, and echogenicity-enhancing
surface dimpling disposed along the needle exterior adjacent and
generally parallel with at least a distal length of the slot.
[0037] The distal end portion of a fiducial deployment system 1000
is described with reference to FIG. 4, which is an external view,
FIG. 4A which is a longitudinal section view taken along line 4A-4A
of FIG. 4, using the needle 800 and fiducial 400 described above,
and FIG. 4B, which shows a transverse section view along line 4B-4B
of FIG. 4A. The system 1000 includes a flexible elongate needle
sheath 1002. The needle 800, including a more flexible proximal
body portion 820 extends through a sheath lumen 1004. At least one
fiducial 400, illustrated here as a plurality of fiducials 400, is
disposed slidably removably in a distal region of the needle lumen
810 of the needle's cannular body. The central longitudinal body
portion 402 substantially occupies the inner diameter of the needle
lumen 810. The protuberance 408 of each fiducial 400 has a height
that may be about the same as the thickness of the needle wall,
including the slot 806 into which the protuberances 408
project.
[0038] The protuberance 408 of the distal-most fiducial 400 is
captured against the tabs 808 of the needle 800. A stylet 1006
configured for use as a pusher is disposed through a portion of the
needle lumen 810 and preferably is configured for actuation from
the proximal end, whereby it can be used to distally advance/push
out the fiducials and/or hold them in place as the needle is
withdrawn from around them. The presence of the fiducials and
stylet in the needle 800 preferably improve its columnar strength
reduce the likelihood that it will get bent, crimped, or otherwise
damaged as it is navigated through and out of the distal end of an
endoscope working channel (not shown).
[0039] FIG. 4B shows a transverse section end view of a section of
a needle 800 (as in FIG. 3) and a fiducial 400 (as in FIGS. 2A-2C).
This view shows the preferred close tolerances and a preferred
orientation of the fiducial body relative to the needle lumen 810
and the protuberance 408 relative to the needle slot 806.
[0040] Several different handle embodiments may be used to effect
advancement and release of one or more fiducials. Certain handle
embodiments are described with reference to FIGS. 7-8D below,
including with reference to the structure and method described
below with reference to FIGS. 4-4B and 5A-5C.
[0041] A method of using the fiducial deployment needle of FIGS.
4-4B is described with reference to FIGS. 5A-5C, with reference to
the structures shown in greater detail in FIGS. 4-4B. In a
preferred method of use, an endoscope 1100 is provided, including a
working channel 1102. In one preferred method, the endoscope is an
EUS endoscope including a distal ultrasound array 1104 configured
for ultrasound imaging. The endoscope 1100 preferably also includes
a video element 1106 (e.g., CCD, optical camera, or other means for
optical visualization). The methods below are described with
reference to placing fiducials 400 at the margins of a tumor 1152
of a patient's pancreas 1150, such that the needle body will be of
sufficient length and navigability (e.g., pushability and
flexibility) to perorally be directed through a patient's
gastrointestinal tract to a target site, including doing so via a
working channel of an endoscope such as a gastric endoscope,
colonoscope, anuscope, or other visualization/procedure-assisting
device.
[0042] The endoscope 1100 is shown in FIG. 5A as having been
directed through a patient's duodenum 1140 until its distal end
portion is adjacent the Sphincter of Oddi 1142, which provides
access to the common bile duct 1144 from which the pancreatic duct
1146 branches and leads to the pancreas 1150.
[0043] As shown in FIG. 5A, the sheath 1002 has been advanced to
the duodenal wall and the needle 800 has been pierced therethrough,
extending near the pancreatic duct 1146 to a location adjacent the
tumor 1152 in the pancreas 1150. As shown in FIG. 5B, the needle
800 is directed to a first target site at a margin of the tumor
1152 (preferably under ultrasound guidance, which can be replaced,
complemented, and/or verified by fluoroscopy or another
visualization technique). Once the distal end 802 of the needle 800
is positioned at the first target, the distal-most fiducial 400
therein is deployed. In one aspect, the deployment may be
accomplished by positioning the distal needle end 802 and the
fiducial 400 therein at the first target, then retracting the
needle 800 while retaining the position of the stylet 1006 such
that the fiducial 400 remains in the desired first target position.
In another aspect, the deployment may be accomplished by
positioning the distal needle end 802 and the fiducial 400 therein
adjacent the first target, then holding the needle 800 in position
while advancing the stylet 1006 such that the fiducial 400 is
advanced into the desired first target position.
[0044] As will be appreciated from the structure of the needle 800
and fiducials 400 as shown in FIGS. 4-4B, a user preferably will be
able to control advancement/deployment of the fiducials to one at a
time, such that a plurality of fiducials (without any spacers) may
serially--but separately and independently--directed into different
locations. Then the fiducial 400 is in a "ready to deploy"
position, its distal protuberance face 408a is engaged against the
proximal tab edges 808a. To deploy the fiducial 400, the user must
move one of the stylet 1006 or needle 800 relative to the other
with sufficient force to advance the protuberance 408 through the
tabs 808.
[0045] The user preferably will have a tactile sense of resistance
as the protuberance 408 passes through the tabs 808, which
resistance will decrease immediately as soon as the protuberance
clears the tabs. Then the user preferably continues the relative
motion of stylet and needle until resistance is again encountered,
indicating that the next fiducial behind the distal-most one has
met the proximal tab edges 808a.
[0046] It will often be preferred that the fiducials (and the
protuberances thereon) be proportioned such that complete
deployment of a distal-most fiducial includes it substantially
clearing the distal needle tip 802 and coincides with the
protuberance of the next distal-most fiducial meeting the proximal
tab edges 808a. As such, it may be advantageous in some fiducial
embodiments to position the protuberance more proximally on the
fiducial body such that a fiducial body portion distal of the
protuberance is longer than a body portion proximal of the
protuberance. It should be appreciated that the protuberance of
almost any fiducial embodiment in keeping with principles of the
present invention may be disposed near the proximal end up to and
including flush with the proximal end of the fiducial body). FIG.
5C shows the fiducial in place, with the needle withdrawn away from
it.
[0047] Next, the user may retract the needle 800 into the sheath
1002 to a sufficient distance allowing it to be re-extended to a
second target site, where the procedure described above may be
repeated. These steps may be repeated for placement of third,
fourth, and further fiducials. As is known in the art, these
fiducials may be used for "positive targeting" and/or "negative
targeting" of a therapy such as radiation therapy ("positive
targeting" indicating "treat here", and "negative targeting"
indicating "do not treat here"). The present system presents
numerous advantages. For example, consider a patient already
undergoing an endoscopy procedure to biopsy a located but
undiagnosed tissue mass. The endoscopic biopsy can be taken and a
tissue slide prepared immediately. If a diagnosis is made (in
conjunction with whatever other data are available and pertinent)
that the tissue mass will benefit from a treatment where placement
of fiducials is indicated, the physician can immediately deploy
fiducials in the manner described above.
[0048] The ability to complete the method using direct/video and
ultrasound imaging with little or no use of fluoroscopy presents an
advantage of minimizing the radiation exposure of the patient (who
may, for example, have to undergo radiation therapies where the
total amount of exposure to radiation is desired to be minimized to
that which is therapeutically and diagnostically necessary).
Advantages of time and expense for the patient, physician and other
treating/diagnostic personnel, and the treatment facility are
likely as implementation of the present method may prevent all of
those entities from having to schedule and conduct a second
endoscopic procedure, and/or to extend the initial diagnostic
procedure with the time-consuming methods and materials currently
available in the prior art as described. It should also be
appreciated that, when informed by the present disclosure, those of
skill in the art may utilize and/or adapt the presently-disclosed
embodiments for percutaneous use while remaining within the scope
of one or more claims.
[0049] Fiducials with generally cylindrical or otherwise generally
regular geometry may migrate after having been placed in a desired
location, including that--over the course of multiple treatments of
a target area delineated by fiducials--they may migrate with
changes in the condition of surrounding tissues. For circumstances
where it may be advantageous to minimize migration, a fiducial may
be used that includes one or more anchoring projections.
[0050] FIGS. 6A-6B show a handle embodiment 1600 that may be used
with a fiducial deployment system. The handle 1600 includes a
sheath-attached handle member 1602 with a needle-attached handle
member 1604 longitudinally slidably disposed on its proximal end. A
handle member 1606 (which may be configured for scope-attachment)
is slidably attached to the distal end of the sheath-attached
handle member 1602. The sheath-attached handle member 1602 is
attached to the needle sheath 1612 and the needle-attached handle
member 1604 is attached to the needle 1614 (which may be configured
in the manner of any of the needles disclosed herein or later
developed in accordance with principles of the present disclosure).
The scope-attachment handle member 1606 is configured for
incrementally fixable, longitudinally-adjustable (relative to the
other handle components) attachment to the exterior of an endoscope
working channel (not shown) using, for example, a threaded cavity
1616. The scope-attachment handle member 1606 allows a user to
determine the distance by which the sheath 1612 will extend from a
standard-length endoscope, and it may include numerical or other
indicia 1617 corresponding to that relative length and an
adjustable engagement structure 1618 allowing a user to select a
length and engage the scope-attachment handle member 1606
accordingly. It should be appreciated that embodiments of the
handle described and claimed herein may be practiced within the
scope of the present invention without including a scope-attachment
member.
[0051] The sheath-attached handle member 1602 includes numerical
indicia 1608 and an adjustable ring 1609 that limits the movement
of the needle-attached handle member 1604 and provides a way to
select the distance to which the needle 1614 may be extended beyond
the sheath 1612. By way of illustration, the configuration shown in
FIG. 6A would allow the sheath to extend 5 units (e.g., inches, cm)
beyond the distal end opening of an endoscope working channel, and
the needle 1614 would not extend at all beyond the distal end of
the sheath 1612. The configuration shown in FIG. 6B would allow the
sheath to extend 3 units (e.g., inches, cm) beyond the distal end
opening of an endoscope working channel, and the needle 1614 would
be allowed to extend up to 6 units beyond the distal end of the
sheath 1612, although its current position would be only about 4
units beyond the distal end of the sheath 1612.
[0052] A stylet 1610 extends through a lumen of the needle 1614 and
has a stylet cap 1611 fixed on its proximal end. The stylet 1610 is
shown as being retracted proximally in FIG. 6A, and extended beyond
the distal end of the needle 1614 in FIG. 6B. The stylet 1610 may
be manually advanced distally through the needle lumen in the same
manner as described above (with reference to FIGS. 4-4B) for a
stylet 1006. As such, a user may use the stylet to manually push
fiducials out of a distal end of the needle 1614. If this method is
used (e.g., in the manner described above for deployment of
fiducials with reference to FIGS. 4-5C), a user may rely upon
tactile feedback to determine when a fiducial has been advanced
beyond any detents, which may be difficult through a long
stylet--particularly if the detents are rounded such that the
advancing motion is relatively smooth. Accordingly, it may be
advantageous to provide an advancement mechanism configured to
attach to (including being integrated with) the handle 1600 that
provides improved control of stylet advancement.
[0053] FIGS. 7-7E show embodiments of advancement mechanisms that
may be used with handle assembly configurations of a fiducial
deployment system similar to those of FIGS. 6A-6B, or other handle
configurations (including, for example, those disclosed in U.S.
Pat. App. Publ. Nos.: 2010/0280367 and 2011/0152611 to Ducharme et
al.; 2013/0006101 to McHugo et al.; 2013/0006286 to Lavelle et al.;
and 2013/0096427 to Murray et al). FIGS. 7-7E show a screw-driven
handle component 1700 for a fiducial deployment system. In this and
other embodiments, the handle component 1700 may be removably or
permanently attached to a proximal end 1605 of a handle, such as
needle-attached handle member 1704, which may be the same as or
operate similar to needle-attached handle member 1604 shown in
FIGS. 6A-6B, where it will provide means for controlled advancement
of a stylet (e.g., stylet 1760 or 1610) in lieu of direct and/or
manual manipulation of the stylet cap 1611.
[0054] In some embodiments, the handle component 1700 (which may be
configured for scope-attachment) may be removably or slidably
attached to a proximal end of sheath-attached handle member 1602
and may be used in lieu of needle-attached handle member 1604.
Sheath-attached handle member 1602 includes numerical indicia 1776
and an adjustable ring 1609 that limits the movement of the
needle-attached handle member 1704 and provides a way to select the
distance to which the needle may be extended beyond the sheath,
such as needle sheath 1622.
[0055] Needle-attached handle member 1704 includes and defines a
central longitudinal axis, a handle lumen, and a proximal end.
Needle-attached handle member 1704 (which in some embodiments may
replace or be attached to the proximal end 1605 of a handle, such
as needle-attached handle member 1604) is attached to a needle 1714
(which may be configured in the manner of any of the needles
disclosed herein or later developed in accordance with principles
of the present disclosure) which extends through at least a portion
of the needle-attached handle member 1704 and the handle lumen
along or generally aligned with its central longitudinal axis.
Needle-attached handle member 1704 may be attached to the needle
1714 by a needle connector, such as a connector 1716 which may be
formed on or protrude laterally from the proximal end of
needle-attached handle member 1704. At least a portion of
needle-attached handle member 1704 is enclosed by or extends
longitudinally through at least a portion of a rotatable housing
member 1706 which includes and defines a central longitudinal axis,
a housing lumen, and an inner wall. Rotatable housing member 1706
also includes and defines housing threads 1706a formed as helical
grooves or ridges on the inner wall of the housing.
[0056] In some embodiments, the connector 1716 may form part of a
single, integral handle member or may be formed as an individual
component removably attached to the distal end of needle-attached
handle member 1704. In other embodiments, the connector 1716 may be
attached to the proximal end of the needle 1714 and retained or
held in place by a tab or detent 1706b, such as, for example,
formed as a longitudinally recessed portion of the inner wall of
the rotatable housing member 1706, although those of skill in the
art will appreciate that retention of needle 1714 with respect to
the rotatable housing member 1706 and/or needle-attached handle
member 1704 may be accomplished by a variety of means without
exceeding the scope of the present disclosure. In some embodiments,
the housing lumen of rotatable housing member 1706 may be
substantially hollow and needle attached handle member 1704 may
extend proximally into the housing lumen. Additionally, ball
bearings or other control mechanisms may be disposed or provided in
the housing lumen to reduce rotational friction and ensure that the
needle does not rotate during fiducially deployment.
[0057] A stylet 1760 extends through at least a portion of the
needle-attached handle member 1704 along or generally aligned with
its central longitudinal axis and the handle lumen. Stylet 1760
likewise extends at least partially through a lumen of the needle
1714 and is operative to deploy to one or more fiducials from the
distal end of the needle 1714. The proximal end of stylet 1760
extends through an opening formed on the proximal end of connector
1716 and is attached to a stylet screw 1720, which defines a distal
end and screw threads 1720a formed as helical grooves or ridges on
an outer portion of the screw. A guide bar 1722 is formed on or
extends in a substantially distal direction from the distal end of
stylet screw 1720 At least a portion of guide bar 1722 extends
through a second opening formed on the proximal end of the
connector 1716 and through at least a portion of the
needle-attached handle member 1704 along or generally aligned with
its central longitudinal axis, such that guide bar 1722 and stylet
1722 are longitudinally slidable and may be advanced in a
substantially distal direction with respect to connector 1716 and
needle-attached handle member 1704 during fiducial deployment.
[0058] With this structure disclosed, those of skill in the art
will appreciate a method of use. FIGS. 7A and 7C show internal
component views and FIGS. 7B and 7D show, respectively,
top-perspective and longitudinal views of the internal components
for this embodiment. In order to distally advance stylet 1760
corresponding to a fiducial-deployment or other distal stylet
movement action (see, e.g., FIGS. 5B-5C), rotatable handle member
1706 may be user actuated or rotated transversely with respect to
the needle-attached handle member 1704. As the user rotates the
housing of rotatable handle member 1706, helical housing threads
1706a formed on the inner wall of housing engage the helical screw
threads 1720a formed on the outer portion of stylet screw 1720. The
angle and bias of the helical threads on both the rotatable housing
and the stylet screw cause the rotational force applied by the user
to be converted to a linear force in order to advance or drive the
stylet screw 1720 in a substantially distal direction with respect
the rotatable handle member 1706 and needle-attached handle member
1704.
[0059] During user-actuated rotation of the rotatable handle member
1706, guide bar 1722 attached to the stylet screw 1720 provides
stabilizing force preventing the stylet screw from rotating
transversely with respect to the needle-attached handle member
1704, although those of skill in the art will appreciate that
preventing rotation of stylet screw 1720 with respect to the
rotatable housing member 1706 and/or needle-attached handle member
1704 may be accomplished by a variety of means without exceeding
the scope of the present disclosure. Rotation of the stylet screw
1720 being prevented, the rotation force of the housing is
efficiently converted to linear force to advance the stylet 1760
and the guide bar 1722 distally through the openings on the
proximal end of connector 1716. Stylet 1760 is distally advanced
through the handle lumen along or generally aligned with its
central longitudinal axis. A controlled amount of rotation applied
to the rotatable housing member 1706 will advance the stylet
forward towards the distal end of the needle 1714--which may be
placed at a target site in or near the gastrointestinal tract
(e.g., liver, pancreas) or other location accessible by endoscopy
(using a minimally invasive endoscope introduced through a natural
patient orifice, e.g., mouth, anus, vagina)--the required distance
to deploy one or more fiducials from the distal end of needle 1714,
depending, in part, on the configuration of handle member 1606 and
sheath-attached handle member 1602, as described further in
connection with FIGS. 6A and 6B.
[0060] In some embodiments, the required rotation to deploy a
pre-determined number of fiducials (e.g., one fiducial or two
fiducials) may correspond to a predetermined amount of handle
rotation (e.g., one full, 360 degree rotation). Upon completion of
the required rotation, the stylet 1760 will have advanced distally
sufficient distance towards the distal end of the needle 1614 to
deploy the desired number of fiducials. In some configurations, the
stylet will have advanced far enough to deploy one or more
fiducials but may remain disposed at least partially within the
needle 1614 and may have one or more additional fiducials disposed
within needle 1614 awaiting deployment. In this scenario,
subsequent numbers of fiducials may be deployed in a serial manner
by additional, successive rotations of housing member 1706. Other
configurations of the sheath-attached handle member 1602 and
needle-attached handle member 1704 may likewise be used to affect
fiducial deployment in a manner similar to as described in
connection with FIGS. 6A and 6B. In one aspect, the mechanism may
be considered as an alternative design for other incremental (e.g.,
one at a time, or "controlled plurality at a time") fiducial
deployment systems, where each actuation corresponding to a stylet
advancement and/or change of exposed numerical indicia corresponds
to deployment of a predetermined number of fiducials such as is
shown, for example, in FIGS. 7A-7C of U.S. Pat. App. Pub. No.
2014/0243844 to Clancy et al., which is incorporated herein by
reference in its entirety. Those of skill in the art will
understand how to operate the present embodiments for controlled
fiducial delivery (one at a time, or in a controlled, predetermined
plurality) with reference to the present figures and
description.
[0061] FIG. 8 shows an external view of a second screw-driven
handle component 1850 for a fiducial deployment system. In this and
other embodiments, the second handle component 1800 may be
removably or permanently attached to a proximal end 1605 of a
handle such as the one shown in FIGS. 6A-6B, where it will provide
means for controlled advancement of a stylet (e.g., stylet 1610) in
lieu of direct and/or manual manipulation of the stylet cap 1611.
In some embodiments, the second handle component 1800 (which may be
configured for scope-attachment) may be removably or slidably
attached to a proximal end of sheath-attached handle member 1602
and may be used in lieu of needle-attached handle member 1604.
Sheath-attached handle member 1602 includes numerical indicia 1608
and an adjustable ring 1609 that limits the movement of the
needle-attached handle member 1804 and provides a way to select the
distance that the needle may be extended beyond a needle sheath,
such as needle sheath 1622.
[0062] FIGS. 8A-8D show an internal components view, two
longitudinal section views, and a top-perspective view of the
internal components of a second advancement mechanism embodiment
for a fiducial deployment system. The second handle component 1800
may include a needle-attached handle member 1804, which includes
and defines a central longitudinal axis, a handle lumen, and a
proximal end. Needle attached handle member 1804 is attached to a
needle 1814 (which may be configured in the manner of any of the
needles disclosed herein or later developed in accordance with
principles of the present disclosure) which extends through at
least a portion of the needle-attached handle member 1804 and the
handle lumen along or generally aligned with its central
longitudinal axis. Needle-attached handle member 1804 may be
attached to the needle 1814 by a laterally protruding portion 1804a
of the handle member, which may be formed on or at the proximal end
of needle attached handle member 1804 and may define an opening in
the handle's proximal end. In some embodiments, the needle may be
attached to a laterally protruding section or portion formed at the
proximal end of a single, integral handle member. In other
embodiments, the needle may be connected to the handle member 1804
by a removably attached connector plate.
[0063] Additionally, second handle component 1800 also includes a
rotatable housing portion 1806, which includes and defines a
central longitudinal axis, a housing lumen, and an inner wall. At
least a portion of needle-attached handle member 1804 is enclosed
by the rotatable housing portion 1806, which includes and defines
housing threads 1806a formed as helical grooves or ridges on the
inner wall of the housing and laterally protruding edges 1806b
formed at the distal end of the housing. In the embodiment depicted
in FIG. 8B, the laterally protruding portion 1804a of the handle
member is engaged by the laterally protruding edges 1806b of
rotatable housing portion 1806 in order to hold the rotatable
housing in place on the proximal end of needle-attached handle
member 1804.
[0064] A stylet 1860 extends through at least a portion of the
needle-attached handle member 1804 along or generally aligned with
its central longitudinal axis and the handle lumen. Stylet 1860
likewise extends at least partially through a lumen of the needle
1814 and is operative to deploy to one or more fiducials from the
distal end of the needle 1814. The proximal end of stylet 1860
extends through an opening formed on the proximal end of
needle-attached handle member 1804 and is attached to a stylet
screw 1820, which defines a distal end and screw threads 1820a
formed as helical grooves or ridges on an outer portion of the
screw. A guide bar 1822 is formed on or extends in a substantially
distal direction from the distal end of stylet screw 1820 At least
a portion of guide bar 1822 extends through a second opening formed
on the proximal end of the connector 1716 and through at least a
portion of the needle-attached handle member 1804 along or
generally aligned with its central longitudinal axis, such that
guide bar 1822 and stylet 1822 are longitudinally slidable and may
be advanced in a substantially distal direction during fiducial
deployment along or generally aligned with the central longitudinal
axis of the handle lumen of needle-attached handle member 1804.
[0065] With this structure disclosed, those of skill in the art
will appreciate a method of use. FIGS. 8A and 8D show an internal
components view and a top-perspective view of the internal
components, respectively, of the second advancement mechanism
embodiment for a fiducial deployment system. FIGS. 8B and 8C show
longitudinal section views of the second advancement mechanism
embodiment for a fiducial deployment system. In order to distally
advance stylet 1860 corresponding to a fiducial-deployment or other
stepwise/incremental distal stylet movement action (see, e.g.,
FIGS. 5B-5C), rotatable housing portion 1806 may be user actuated
or rotated transversely with respect to the needle-attached handle
member 1804. As the user rotates the housing of rotatable housing
portion 1806, helical housing threads 1806a formed on the inner
wall of housing engage the helical screw threads 1820a formed on
the outer portion of stylet screw 1820. The angle and bias of the
helical threads on both the rotatable housing and the stylet screw
cause the rotational force applied by the user to be converted to a
linear force in order to advance or drive the stylet screw 1820 in
a substantially distal direction with respect the rotatable housing
portion 1806 and needle-attached handle member 1804.
[0066] During user-actuated rotation of the rotatable housing
portion 1806, guide bar 1822 attached to the stylet screw 1820
provides stabilizing force preventing the stylet screw from
rotating transversely with respect to the needle-attached handle
member 1804, although those of skill in the art will appreciate
that preventing rotation of stylet screw 1820 with respect to the
rotatable housing portion 1806 and/or needle attached handle member
1804 may be accomplished by a variety of means without exceeding
the scope of the present disclosure. Rotation of the stylet screw
1820 being prevented, the rotation force of the housing is
efficiently converted to linear force to advance the stylet 1860
and the guide bar 1822 distally through the opening on the proximal
end of needle-attached handle member 1804 formed by the laterally
protruding edges 1804a. Stylet 1860 is distally advanced through
the handle lumen along or generally aligned with its central
longitudinal axis. A controlled amount of rotation applied to the
rotatable housing member 1806 will advance the stylet forward
towards the distal end of the needle 1814--which may be placed at a
target site in or near the gastrointestinal tract (e.g., liver,
pancreas) or other location accessible by endoscopy (using a
minimally invasive endoscope introduced through a natural patient
orifice, e.g., mouth, anus, vagina)--the required distance to
deploy one or more fiducials from the distal end of needle 1814,
depending, in part, on the configuration of handle member 1606 and
sheath-attached handle member 1602, as described further in
connection with FIGS. 6A and 6B.
[0067] In some embodiments, the required rotation to deploy a
pre-determined number of fiducials (e.g., one fiducial or two
fiducials) may correspond to a predetermined amount of handle
rotation (e.g., one full, 360-degree rotation). Other
configurations of the sheath-attached handle member 1602 and
needle-attached handle member 1704 may likewise be used to affect
fiducial deployment in a manner similar to as described in
connection with FIGS. 6A and 6B. Upon completion of the required
rotation, the stylet 1860 will have advanced distally sufficient
distance towards the distal end of the needle 1614 to deploy the
desired number of fiducials. In some configurations, the stylet
will have advanced far enough to deploy one or more fiducials but
may remain disposed at least partially within the needle 1614 and
may have one or more additional fiducials disposed within needle
1614 awaiting deployment. In this scenario, subsequent numbers of
fiducials may be deployed in a serial manner by additional,
successive rotations of housing member 1806.
[0068] Those of skill in the art will appreciate with reference to
the embodiments disclosed above that a predetermined number of
fiducials may be released into a desired location by a single
actuation of the lever, button, rotatable housing, or other
actuation member. The predetermined number preferably will be one,
but may include a plurality of fiducials. The configuration of the
present embodiments provide clear advantages over prior designs
that utilize releasable end-plugs in a needle to retain fiducials,
and/or that use less refined means of controlling the fiducial
release than the notch/tab needle design and/or actuation handles
described herein. Drawings and particular features in the figures
illustrating various embodiments are not necessarily to scale. Some
drawings may have certain details magnified for emphasis, and any
different numbers or proportions of parts should not be read as
limiting, unless so-designated by one or more claims. Those of
skill in the art will appreciate that embodiments not expressly
illustrated herein may be practiced within the scope of the present
invention, including that features described herein for different
embodiments may be combined with each other and/or with
currently-known or future-developed technologies while remaining
within the scope of the claims presented here. For example, a
needle and fiducials of the present system may be used
percutaneously, including in another minimally invasive surgical
procedure, such as a laparoscopic-type procedure, within the scope
of the claimed invention. For example, a target site may be a
location in or near the gastrointestinal tract (e.g., liver,
pancreas) such as those locations that may be accessible by
endoscopy (using a minimally invasive endoscope introduced through
a natural patient orifice, e.g., mouth, anus, vagina). This
includes--more broadly--sites reachable through NOTES (natural
orifice translumenal endoscopic surgery) procedures. The present
method and device may also be used with other minimally-invasive
surgical techniques such as percutaneous endoscopic procedures
(e.g., laparoscopic procedures) or percutaneous non-endoscopic
procedures, but most preferably is used with less invasive
endoscopy procedures. It is therefore intended that the foregoing
detailed description be regarded as illustrative rather than
limiting. And, it should be understood that the following claims,
including all equivalents, are intended to define the spirit and
scope of this invention.
* * * * *